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Surprised and impressed by the action. Doesn’t seem fake.
However, we are still only $7, compared to $12-15 before AD results.
Trial or drug not a scam. The CEO is incompetent — and whether the drug or not (in FDA’s definition) is a big question mark.
December 2022 PR and CC were BIG lies from CM —- maybe they were good for the company (in his perspective), but lies nevertheless.
The PR itself suggests the company is lost — list of pipeline trials with no timeframe (already 1 year late on many, and likely 1-2 years more — so why list them?! Because there is nothing else the company has to say !)
Woah — you dream big, man. Good luck.
Fundamentals must support the technicals for a big move (eg to $9.5).
And, you have been here for years? That’s very smart/wise of you.
Technically, great action today.
Fundamentally, very weak.
1.
By all stretches of imagination, P2b/P3 was a failure wrt FDA.
2.
EXCELLENCE data is hugely delayed (which can only mean one thing —- more of the same == unconvincing data).
Why is EXCELLENCE results taking 6 months? Data engineering? Change endpoints?
For comparison, SRPT’s recent EMBARK trials last visit was early-mid September — nearly-full results PR’ed 10/31 AFTER already meeting with FDA executives.
FDA doesn’t get swayed by anyone else. Rightly so.
AVXL has zero approval chance from FDA at this point — why? Because CM I has done nothing about it for 1.5 years, so he is himself telling us.
But it’s not a headline.
Do you know what that means?
No one trusts what comes out of avxl/cm. I can easily find multiple pieces of information missing to create any scientific statement out of it..
The closest is Exondys 1000 people showed up at the AdCom, 140 Congressmen wrote a letter to FDA, Marci Rubio gave a speech in senate. And, much more.
None of it mattered. FDA did approve but if you know the details of the saga, it was a reject by FDA until Janet Woodcock decided to make a unilateral decision .
All I can say is that FDA is extremely scrutinizing. You should attend some of their AdComs and/or read some of their briefing documents to see what it takes to convince FDA.
SRPT seemed to have it all under control for the recent gene therapy ---- they were using MICRO-dystrophin as a surrogate marker, and FDA had already accepted MINI-dystrophin as a surrogate marker in the past. Now, the SRPT CEO's argument (very detailed answer he gave in one of the CC's) was that micro-dystrophin is essentially "similar" as the mini-dystrophin -- so FDA shouldn't have a problem.
FDA completely ignored the similarity. They looked at micro-dystrophin as a FRESH biomarker. And, they wanted to see PLACEBO-CONTROLLED TRIALS that showed that "micro-dystrophin expression ----> functional benefit". That's it. There was just no way around this requirement. And, SRPT was slight short on that requirement (their placebo-controlled trial had succeed for 4-5 year olds, but failed for 5-7 year olds, in 2020). So, FDA approved only for 4-5 year olds (a very narrow label -- which imo is almost a CRL).
Also -- even if FDA were to accept reduction in brain volume loss as a marker -- the big Q will be -- how much is clinically meaningful? Unless the reduction is too obviously meaningful (not sure what would that amount be), the only way to answer this Q is via placebo-controlled trails which shows "reduction in loss of brain volume ---> functional improvement".
Thanks for some of the info. Two comments.
1. I doubt FDA would accept brain volume as a surrogate marker (I gave my readings in an earlier list). But it may.
2. Biggest issue I see is dosage arm data. Since CM hasn’t released it, I’m inclined to think that dose-level data is not statistically significant and/or has other issues. FDA will certainly not approve based on pooled data — that’s guaranteed.
NO, no precedence.
I would think OLE being a confirmatory trial is CM's pipe-dream.
FDA would want a double-blinded placebo-controlled trial.
Huge delays makes it very suspicious. History can’t be refuted.
Is there any study that has shown that “reducing the loss of brain volume” improves Alzheimer’s?
That is exactly what FDA would want. Studies that show that Alzheimer’s patients undergo a loss of brain volume — wouldn’t cut it (infect they are even irrelevant).
And, then, there can’t possibly be studies that show the above — unless the recent trials of BIIB or LLY have shown it. Have they?
Now in case of cancer — the tumor size is indicative of cancer growth, and reducing the tumor size is much more obviously an improvement of cancer.
You are likely a baby. In 20s? Maybe early 30s.
Investment requires wisdom — comes with age, among other things.
It seems to me that the most likely scenario, by a lot, is that the slowing of whole-brain volume shrinkage, as reported by Anavex, is an excellent indicator, and that you're needlessly (from bias perhaps?) casting doubt on it.
Why is your/others obsession only with negative posters, and not with bullish ones?
The bullish ones can’t be paid posters? They are non-anonymous? They are being truthful?
Exactly.
CM claims ORs to be the endpoint measures based on SAP, in response to Sumit’s Q post CTAD call in 12/22.
Now, he is instead claiming success based on LSM (sidelining ORs).
Neither of them was ever comminuted by CM before 12/22. Neither of them is the standard measure of change in mean — that the whole world uses.
Of course, the flip-flop is not relevant to the NDA or FDA. But just shows that he’s playing a sleazy game with the market and investors. And, the market is punishing.
People who believe that ADL mean-change reached statistical significance are completed blindfolded in their love for the company.
Nothing else they say can be believed.
This too after 9 months of silence from the company over MOST KEY piece of missing information.
CEOs, in all likelihood, have a LEGAL right to not reveal “everything” to the public. Of course — since revealing “everything” is practically impossible.
They are however required to reveal material information— but what is “material” can be very subjective.
So, CM not revealing all the adverse events in P2a is very likely legal — in which case, why should he reveal it?
SRPT had been very transparent and forthright — but they still hid the actual WB dystrophin expression number in Etepletsin’s trial from public (public came to know about it only through 2016 FDA’s briefing documents). I was quite shocked, that they hid — but I realize they weren’t obligated to reveal, so why would they expose themselves unnecessarily.
Same reason — AVXL doesn’t want to reveal ADL numbers. That’s fine — but going back-and-forth with endpoint measures is plain lying — and must be of questionable legality.
Yes, exactly. Dec 1 PR is of zero relevance to FDA. FDA will base its decision on NDA.
I don’t know for sure — but it must not be simple. But, it would be class action — so the damages will not be based on a particular shareholder (I think). Lawyers will get together and make a settlement, and distribute and settle.
How much did the share price go down *because* of the (alleged) lie? You see it’s not simple to determine that. But future appreciation (way past the lie) shouldn’t play much role (for one, holding a stock has risk too).
p = 0.0005 means that less shrinkage was universally the case, not just "some".
We disagree. And, that's fine.
You seem to care a lot about likes. I don’t.
I say what I mean and mean what I say.
CM’s lies and imo borderline-fraudulent/scamming behavior certainly infuriates me (I have a big position, so it matters) — and such behavior (likely illegal) shouldn’t go unpunished.
It’s impossible to refute his two specific lies: (1) About AUC in Avatar, (2) ORs being the actual endpoint measures in Dec PR.
That is not how damages are calculated. You can’t nullify by damages by future increase in share price.
Exactly —- too much slicing and dicing (aka, data mining) going on in desperation to claim success. Lots of lies and manipulation. It’s unbelievable.
The most unfortunate part is that CM still hasn’t learned how to present results (look at the new biomarker data!!) —- still cherry picking and dishing out incomplete information.
The fear is that he may do that even with completely perfect data!! I certainly got fooled when Avatar data came out — and really believed him that AUC wasn’t a trick, but a genuine additional endpoint to make better sense of the data (to make FDA happier). He proved me wrong in the recent CC. I wish him the worst .. I really do. He’s an FRAUD and SCAMMER. Hope he (personally) goes bankrupt and in jail!
So why did they not use the genome analysis in design of P2b/3?
I really think (for the first time) that the flip-flop on what the primary endpoint measures (ORs as per Dec 22 release, and LSM now) really makes AVXL open to lawsuits.
IR is making a fool of everyone.
I’d say CM seems hardwired to telling lies.
AVXL deserves to be much higher -- but it is not because the market hates/distrusts the CEO.
And you really think AVXL has had any discussions with FDA? Especially, with OR endpoints? That will be mighty stupid of AVXL to present ORs as endpoints to FDA -- CM isn't THAT stupid.
AVXL doesn't need to explain anyone (least of all FDA) about "dropping" ORs. They just won't use ORs as primary endpoints when submitting an NDA to FDA, if at all. FDA doesn't care about the PRs issued.
I understand that LSM seems to have worked for their purposes. But why would FDA accept it? I mean … this again seems like finding some outcome measure (like ORs before) which is serving their purpose — that’s gotta be trashed by FDA.
What’s the justification to use LSM differences rather than simple means?
If you really think ADL was stat-sig after this PR, you truly are blindfolded in love with your investment.